Global Regulatory Leader: Early & Late-Phase

Lilly; Indianapolis (IN); On-site; USD 176,000 - 257,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Employee well-being programs

Job summary

Lilly in Indianapolis is seeking a Global Regulatory Lead to drive global regulatory strategies from development through lifecycle. You will lead a cross-functional team, oversee US FDA submissions, and shape interactions with health authorities to support registration goals.

The role requires 8+ years in regulatory affairs or drug development, with an advanced degree preferred. Travel 10–15% and relocation to Indianapolis is provided.

Qualifications

• Bachelor’s Degree in a scientific or related field.
• 8+ years of regulatory affairs and/or drug development experience.
• Advanced degree preferred (e.g. Master’s, PharmD, PhD).

Responsibilities

• Develop and execute global regulatory strategies throughout product lifecycle.
• Oversee US FDA submissions (INDs/NDAs/BLAs) and agency interactions.
• Lead a cross-functional Global Regulatory Team and coordinate with GBD teams.
• Ensure affiliate regulatory plans align with global strategy and business priorities.

Skills

Regulatory strategy

FDA interactions

Leadership

Cross-functional leadership

Education

Bachelor's Degree

Advanced degree preferred

Job description

Lilly in Indianapolis is seeking a Global Regulatory Lead to drive global regulatory strategies from development through lifecycle. You will lead a cross-functional team, oversee US FDA submissions, and shape interactions with health authorities to support registration goals.

The role requires 8+ years in regulatory affairs or drug development, with an advanced degree preferred. Travel 10–15% and relocation to Indianapolis is provided.